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Spineology, Inc.
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Spineology Interbody Fusion System is an FDA 510(k)-cleared medical device (DEN200010) manufactured by Spineology, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 2020. Regulation: 8.